Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as skin irritation and the available information indicates that it should be classified as eye irritation (Category 2)
Justification for type of information:
The UVCB intermediate substnace is classified as skin irritant category 2 and thus, there is no need for Eye irritation test as perREACH regulation. Two methods are applied, First, all constituents CLP data are analyzed using substance analytical information and ECHA database for CLP data. Results are compared with criteria from CLP regulation to derive proper classification according to CLP guideline. Four constituents with CAS numbers 5989 -27 -5 (7.7%) , 108 -38 -3 (4.07%), 99 -87 -6 (4.56%), 108 -88 -3 (4.04 %) , 100 -42 -5 (2.56%), 1195 -32 -0 (1.01%) , and 627 -20 -3(1.76%) contribute to more than 10% irritant 2 properties. Thus, the substance can be classified as Irritant category 2 according to CLP regulation.
In addition, By applying Danish DTU QSAR database; three of the constituents from set of actual constituents in substance analytical information combined with C>4 representative data are determined positive for severe skin irritation in Rabbit. The result is based on Battery model using all systems of CASE Ultra, Leadscope, SciQSAR and experimental from training set. The model is set for determining positive results in applicability domain.
Therefore, it can be concluded that the substance is already Skin irritant category 2 and there was no need for further eye irritation test.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion